Trials / Completed
CompletedNCT04287920
Acamprosate Safe to Use in Individuals With Liver Disease.
A Phase II Study Evaluating the Safety of Acamprosate for Alcohol Use Disorder in Alcohol-related Liver Disease
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 12 (actual)
- Sponsor
- Mayo Clinic · Academic / Other
- Sex
- All
- Age
- 21 Years
- Healthy volunteers
- Not accepted
Summary
Is acamprosate safe to use in individuals with liver disease.
Detailed description
Adult patients aged 21 or over with a diagnosis of alcohol-related liver disease and alcohol use disorder (AUD) and abstinent from alcohol for at least 2 weeks (but not more than 6 months) prior to initiating acamprosate treatment.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Acomprosate | Acamprosate will be administered orally and will be dosed at 333 mg three times a day, if tolerated it will be increased to 666 mg three times a day. Acamprosate will be administered for a total of 3 months |
Timeline
- Start date
- 2020-09-21
- Primary completion
- 2022-01-05
- Completion
- 2022-01-05
- First posted
- 2020-02-27
- Last updated
- 2022-12-20
- Results posted
- 2022-12-20
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04287920. Inclusion in this directory is not an endorsement.